Sapien Robotics
Aseptic Manufacturing - Subject Matter Expert
Sapien Robotics, San Francisco, California, United States, 94199
About the Role
We are seeking an exceptional Subject Matter Expert in Aseptic operations to spearhead the development of next-generation robotic cells for aseptic fill and finish operations. This pivotal role combines deep expertise in small and large batch aseptic manufacturing with cutting-edge robotics integration, positioning you at the forefront of pharmaceutical automation innovation. As a key technical leader, you will collaborate directly with our robotics engineering team to develop the most advanced robotic systems for sterile pharmaceutical manufacturing, specifically focused on small batch aseptic fill and finish processes that are transforming modern pharmaceutical production. Key Responsibilities
Lead technical development of robotic cells for aseptic fill and finish operations, ensuring FDA, EMA, and ICH compliance Serve as primary SME for aseptic manufacturing processes, sterility assurance, and contamination control in robotic environments Design and optimize aseptic workflows for robotic systems handling RTU vials, syringes, and cartridges Lead process validation activities including media fills, sterility testing, and environmental monitoring for automated systems Collaborate with robotics engineers to specify cleanroom-compatible systems with ISO 5 particle emission standards Develop SOPs, batch records, and validation protocols for automated aseptic processes Drive continuous improvement initiatives focused on contamination reduction and throughput optimization Technical Expertise
Deep knowledge of aseptic processing, cleanroom operations (ISO 5-8), and sterility assurance Comprehensive understanding of FDA 21 CFR Part 211, EU Annex 1, and ICH guidelines Experience with small and large batch production challenges and contamination prevention strategies Proven background in process validation, qualification (DQ/IQ/OQ/PQ), and GMP documentation Knowledge of robotics applications in pharmaceutical manufacturing Job Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Management and Manufacturing #J-18808-Ljbffr
We are seeking an exceptional Subject Matter Expert in Aseptic operations to spearhead the development of next-generation robotic cells for aseptic fill and finish operations. This pivotal role combines deep expertise in small and large batch aseptic manufacturing with cutting-edge robotics integration, positioning you at the forefront of pharmaceutical automation innovation. As a key technical leader, you will collaborate directly with our robotics engineering team to develop the most advanced robotic systems for sterile pharmaceutical manufacturing, specifically focused on small batch aseptic fill and finish processes that are transforming modern pharmaceutical production. Key Responsibilities
Lead technical development of robotic cells for aseptic fill and finish operations, ensuring FDA, EMA, and ICH compliance Serve as primary SME for aseptic manufacturing processes, sterility assurance, and contamination control in robotic environments Design and optimize aseptic workflows for robotic systems handling RTU vials, syringes, and cartridges Lead process validation activities including media fills, sterility testing, and environmental monitoring for automated systems Collaborate with robotics engineers to specify cleanroom-compatible systems with ISO 5 particle emission standards Develop SOPs, batch records, and validation protocols for automated aseptic processes Drive continuous improvement initiatives focused on contamination reduction and throughput optimization Technical Expertise
Deep knowledge of aseptic processing, cleanroom operations (ISO 5-8), and sterility assurance Comprehensive understanding of FDA 21 CFR Part 211, EU Annex 1, and ICH guidelines Experience with small and large batch production challenges and contamination prevention strategies Proven background in process validation, qualification (DQ/IQ/OQ/PQ), and GMP documentation Knowledge of robotics applications in pharmaceutical manufacturing Job Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Management and Manufacturing #J-18808-Ljbffr